Evaluation of Music on the Level of Anxiety Felt During External Radiotherapy Sessions

NCT ID: NCT05289505

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2023-03-26

Brief Summary

This is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device.

Detailed Description

The retrospective phase (historical comparator) includes all patients with an initial HADS score > 7 who were treated with radiotherapy during 6 months preceding the start of the prospective study. The prospective phase involves all patients with an initial HADS score > 7 who will be treated with radiotherapy and who will benefit from music sessions (MUSIC-CARE). The study will be conducted over a fixed period of 12 months (6 months recruitment and 6 months follow-up) from the first patient receiving music sessions. Anxiety will be assessed by HADS self-questionnaires, before radiotherapy, at the end of the first week and at the end of radiotherapy. These evaluation parameters will therefore be compared to the 6-month period prior to the start of the study (retrospective phase).

Conditions

Radiotherapy Side Effect

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective phase

This prospective phase involves all patients with an initial HADS score \> 7 and initiating treatment in the radiotherapy department. The treatment sessions will be performed with music, using the MUSIC-CARE device. In the event of technical problems, unavailability of equipment, or the patient's wishes, some radiotherapy sessions may be conducted without music. Nevertheless, a minimum of one weekly session with music is required for the analysis of the study.

MUSIC-CARE

Intervention Type: DEVICE

This device allows the listening of music using different sequences of instrumental music created specifically, and using principles based on hypno-analgesia, that is to say the association of hypnotic techniques and approaches to help or analgesic, medicated or not. It consists of a tablet application containing instrumental music pieces, specially created and recorded for Music-Care. Each piece is at least 20 minutes long. The music can be played through headphones or speakers.

Interventions

MUSIC-CARE

This device allows the listening of music using different sequences of instrumental music created specifically, and using principles based on hypno-analgesia, that is to say the association of hypnotic techniques and approaches to help or analgesic, medicated or not. It consists of a tablet application containing instrumental music pieces, specially created and recorded for Music-Care. Each piece is at least 20 minutes long. The music can be played through headphones or speakers.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age
• Patients undergoing radiotherapy for curative treatment
• Patients with at least 15 sessions of radiotherapy
• Patients with an anxiety score > 7 on the total A of the HADS scale at the time of medical consultation

Exclusion Criteria

• Minor patients
• Pregnant or breastfeeding patients
• Patients with major hearing loss
• Patients with psychotic disorders
• Patients who do not understand or read the French language
• Patients under guardianship or deprived of liberty
• Patients requiring radiotherapy with respiratory servo-control (the MUSIC-CARE cannot be used due to technical constraints)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coralie Hulot

Role: PRINCIPAL_INVESTIGATOR

Centre de Lutte contre le Cancer Eugène Marquis

Locations

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

Countries

France

Other Identifiers

2021-A00597-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-6-63-004

Identifier Type: -

Identifier Source: org_study_id